Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Catalog No. 0930-9-003
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Stryker Howmedica Osteonics Corp.
Reason for Recall:
Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.

Product Codes/Lot Numbers:

Catalog No. 0930-9-003

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2396-2016

Related Recalls

Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mechanism of the Transport Struts.

Apr 26, 2017 Implants & Prosthetics Nationwide View Details →

Reunion TSA Peg Alignment Sound broke during surgery.

Dec 2, 2016 Implants & Prosthetics Nationwide View Details →

A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.

Nov 9, 2016 Other Medical Devices Nationwide View Details →